The following data is part of a premarket notification filed by Jomed, Inc. with the FDA for Jowire Asahi Ptca Catheter Guide Wires, Models Ag145300,141300,142300,132200,14m350,14m345,14m360,143390,141002.
| Device ID | K031277 |
| 510k Number | K031277 |
| Device Name: | JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 |
| Classification | Wire, Guide, Catheter |
| Applicant | JOMED, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Terry Schultz |
| Correspondent | Terry Schultz JOMED, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-22 |
| Decision Date | 2003-05-14 |
| Summary: | summary |